Reported Apr 19, 2023 · Terminated
Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40);…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40) |
| 2 | packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44) |
| 3 | Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India |
| 4 | Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512. |
- Lot codes and dates
- Lot Number
G1510001Exp 11/2023G151002Exp. 12/2023and G151003Exp 02/2024
- Lot Number
- Amount recalled
- 16,450 vials
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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